Medical device for providing port-like access to a mammalian urinary system and methods of inserting and utilizing the same

ABSTRACT

A medical device for providing direct port-like endoscopic access to the urinary bladder, or other orifice, of a patient and a method of utilizing and inserting the medical device. The medical device can include a hollow tube with a main channel and a separate channel, a cap with an inflation port and a hollow flexible stem fluidly connecting the inflation port and the separate channel. A method can include inserting a needle above the pubic symphysis of a mammal, threading a guide wire through the needle, removing the needle and inserting the medical device. The method can optionally include determining measuring the depth between the skin surface of the patient&#39;s suprapubic region and urinary bladder.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a Continuation of U.S. patent application Ser. No.13/887,137, filed on May 3, 2013, titled A MEDICAL DEVICE FOR PROVIDINGPORT-LIKE ACCESS TO A MAMMALIAN URINARY SYSTEM AND METHODS OF INSERTINGAND UTILIZING THE SAME, which is a Continuation-in-Part of U.S. Pat. No.8,870,852, titled A MEDICAL DEVICE FOR PROVIDING PORT-LIKE ACCESS TO AMAMMALIAN URINARY BLADDER AND METHODS OF INSERTING AND UTILIZING THESAME, filed on Aug. 24, 2012, the disclosures of which are herebyincorporated by reference in their entireties.

TECHNICAL FIELD

The present disclosure relates generally to a medical device forproviding direct port-like endoscopic access to the urinary system of apatient. More particularly, the medical device is low profile, designedfor long term use and allows an operator to drain the urinary system oraccess the urinary system with minimal effort.

BACKGROUND

Access to the urinary bladder of a patient is sometimes necessary totreat a patient or to drain urine from the bladder of a patient. Forexample, in some instances the normal urinary flow of a patient may beblocked for one or more reasons. Some of these reasons include theswelling of the prostate (benign prostatic hypertrophy), congenitaldefects of the urinary tract, traumatic disruption of the urethra,obstructions such as kidney stones passed into the urethra, and cancer.When the normal urinary flow of the patient is obstructed asurgically-created connection between the urinary bladder and the skin,sometimes referred to as suprapubic cystostomy, is used to drain urinefrom the bladder. In a suprapubic cystostomy, medical personnel insert acatheter into the patient to allow urine to drain from the bladder. Thecatheters used in these procedures have several disadvantages, includingtheir bulky size which leaves the patient with a large catheterprotruding from the placement site. In some circumstances, medicalpersonnel may place a Foley catheter into the patient's bladder via theurethra. This is uncomfortable for the patient and can easily becomeinfected unless necessary precautions are taken, for example, drinkingsufficient amounts of water, infrequently disconnecting the drainage bagand limiting sexual activity. As sexual activity of the elderlypopulation increases the need to decrease or limit sexual activity inelderly patients has become an increasing concern.

Another instance where access to the urinary bladder of a patient issometimes necessary is when medical personnel need to performintra-bladder or intra-urethral procedures, for example, removingbladder stones, performing bladder biopsies, performing retrogradepyelograms, performing cystograms, and ureteral stent placement andremoval. In these instances medical personnel often use a cystoscope oralternative devices to provide both visual and mechanical access to theimmediate and surrounding procedure area via a patient's urethra. Eachtime access is necessary, a narrow tube is passed through the urethrainto the bladder which allows medical personnel to use a light, camera,and tools to diagnose and treat bladder problems.

Like the use of a Foley catheter, this procedure is uncomfortable forthe patient and requires repeating the entire process every time accessis necessary.

SUMMARY

One aspect is a device for providing direct port-like endoscopic accessto the bladder of a patient to assist the operator in performingintra-bladder or intra-urethral procedures, e.g., removing bladderstones, performing bladder biopsies, performing retrograde pyelograms,performing cystograms, ureteral stent placement and removal, flexibleureteroscopy, performing bladder instillations, bladder cycling andbladder training, mucous removal, and matrix stone removal.

In some embodiments, the device improves a patient's ability to draintheir bladder. The device is easier to place and may be placed in anexisting suprapubic tract by stage and/or primary placement. The deviceallows for easier exchange in the office rather than operating roomafter initial placement and may allow for patients to change at home, orbe changed by nursing home staff or visiting nurses, thereby increasingphysician availability for new patient visits and decreasing patient andinsurance costs for repeat physician office procedural visits.

In some embodiments, the medical device is designed for and may beplaced through the back of the patient so that the medical deviceterminates in the patient's kidney. Placement of the device between thepatient's back and kidney allows medical personal to both drain fluidfrom the kidney and to have direct port-like access to the patient'skidney.

In other embodiments, the medical device is designed for and may beplaced directly into the patient's urethra to become a low profilealternative to currently available products and to allow the patient toeasily drain their bladder by simply opening the cap to the medicaldevice.

In some embodiments, a medical device comprises a continuous hollow tubefor spanning the distance between an exterior surface of a patient'ssuprapubic region and the patients urinary bladder having a diameterbetween 10 french and 40 french and a length between 0.8 cm and 15 cm.The hollow tube has an open proximal end and an open distal end, theproximal end of the hollow tube being longitudinally more rigid than thedistal end.

The medical device may also comprise a first cap having a top surfaceand bottom surface that is operatively configured for securely attachingto the proximal end of the tube. The cap covers the open proximal end ofthe tube when securely attached to the proximal end of the tube and thebottom surface of the cap is recessed within the proximal end of thetube when securely attached.

The medical device may further comprise a hollow flexible stem fluidlyconnecting the cap and the proximal end of the hollow tube so thatliquid may pass into the bottom surface of the cap, through the hollowflexible stem and into a separate channel within the hollow tube. Thefluidly separate channel runs from the proximal end of the hollow tubetoward the distal end of the hollow tube and the hollow flexible stem ispermanently attached to the hollow tube below the open proximal end ofthe hollow tube.

The medical device may also comprise an inflation port on the bottomsurface of the cap, the inflation port is operatively configured toreceive liquid via a syringe so when the cap is not securely attached tothe proximal end of the tube, liquid may be injected via the inflationport and travel from the cap, through the hollow flexible stem and downthe separate channel within the hollow tube.

In some embodiments a medical device may comprise a second cap having atop surface and a bottom surface that is operatively configured tosecurely attach to the proximal end of the tube. The second cap may haveat least one port from the top surface through to the bottom surface. Inaddition a medical device may comprise a one way valve located withinthe tube of the medical device to prevent liquid from traveling from thepatient's urinary bladder to the proximal surface of the patient'ssuprapubic region when the first cap is not securely attached to theproximal end of the tube.

A variation of a medical device may comprise an inflatable balloon alongthe exterior surface (or partially interior surface) of the hollow tubeand in fluid communication with the inflation port via the separatechannel within the hollow tube.

In certain embodiments, a medical device of the present disclosure willsit substantially flush with the skin of the suprapubic region of thepatient after insertion of the device into the patient. And in someembodiments the inflation port of the device sits at least partiallybeneath the skin of the suprapubic region of the patient after insertionof the device and when the cap is securely attached to the proximal endof the tube.

A medical device of the present disclosure, in some instances, will havea medial region located between the proximal end and the distal end ofthe hollow tube where the rigidity of the medial region is less than theproximal end and greater than the distal end.

In an embodiment of the present disclosure a method for inserting amedical device is disclosed, comprising the following steps: Inserting aneedle from a patient's exterior surface of a suprapubic skin through tothe patient's abdominal region and into the patient's urinary bladder tocreate a tract; threading a guide wire through the needle so the guidewire travels from the suprapubic skin of the patient into the urinarybladder of the patient; removing the needle while leaving the guide wirein the tract; dilating the tract to a desired width; measuring adistance between the patient's suprapubic skin and the patient's urinarybladder via the tract; and inserting a medical device suitable for usebased on the previously measure distance.

A method for replacing a medical device is disclosed in the presentdisclosure, one embodiment comprising: placing a guide wire from apatient's suprapubic skin through the patient's abdominal region andinto the patient's urinary bladder, the guide wire traveling from thesuprapubic skin into the urinary bladder within a previously placedmedical device; removing the previously placed medical device by slidingthe device along the guide wire and away from the patient; filling thebladder of the patient; measuring a distance between the patient'ssuprapubic skin and the patient's urinary bladder; selecting a secondmedical device suitable for use based on the previously measuredistance; inserting the selected medical device; and draining theurinary bladder of the patient.

Another aspect is a medical device comprising: a continuous hollow tube,the length sized for spanning the distance between an exterior surfaceof a mammal's back and the mammal's pelvis of its kidney, the hollowtube having an open proximal end and an open distal end; a first caphaving a top surface and a bottom surface, the first cap beingoperatively configured for securely attaching to the proximal end of thetube; a hollow flexible stem fluidly connecting the first cap and theproximal end of the hollow tube so that liquid may pass into the bottomsurface of the first cap, through the hollow flexible stem and into aseparate channel within the hollow tube; and an inflation port on thebottom surface of the cap.

A further aspect is a medical device comprising: a continuous hollowtube, the length sized for spanning the distance between an exteriorsurface of a mammals skin and the mammal's pelvis of the kidney having adiameter between 10 french and 40 french, the hollow tube having an openproximal end and an open distal end; a first cap having a top surfaceand bottom surface that is operatively configured for securely attachingto the proximal end of the tube, the cap covering the open proximal endof the tube when securely attached to the proximal end of the tube, thebottom surface of the cap being recessed within the proximal end of thetube upon secure attachment; a hollow flexible stem fluidly connectingthe cap and the proximal end of the hollow tube so that liquid may passinto the bottom surface of the cap, through the hollow flexible stem andinto a separate channel within the hollow tube, the fluidly separatechannel running from the proximal end of the hollow tube toward thedistal end of the hollow tube, and the hollow flexible stem beingpermanently attached to the hollow tube below the open proximal end ofthe hollow tube; and an inflation port on the bottom surface of the cap,the inflation port being operatively configured to receive liquid via asyringe so when the cap is not securely attached to the proximal end ofthe tube liquid may be injected via the inflation port and travel fromthe cap, through the hollow flexible stem and down the separate channelwithin the hollow tube.

Yet another aspect is a medical device comprising: a continuous hollowtube, the length sized for spanning the distance between an exteriorsurface of a mammals skin and the mammal's bladder having a diameterbetween 10 french and 40 french, the hollow tube having an open proximalend and an open distal end; a first cap having a top surface and bottomsurface that is operatively configured for securely attaching to theproximal end of the tube, the cap covering the open proximal end of thetube when securely attached to the proximal end of the tube, the bottomsurface of the cap being recessed within the proximal end of the tubeupon secure attachment; a hollow flexible stem fluidly connecting thecap and the proximal end of the hollow tube so that liquid may pass intothe bottom surface of the cap, through the hollow flexible stem and intoa separate channel within the hollow tube, the fluidly separate channelrunning from the proximal end of the hollow tube toward the distal endof the hollow tube, and the hollow flexible stem being permanentlyattached to the hollow tube below the open proximal end of the hollowtube; and an inflation port on the bottom surface of the cap, theinflation port being operatively configured to receive liquid via asyringe so when the cap is not securely attached to the proximal end ofthe tube liquid may be injected via the inflation port and travel fromthe cap, through the hollow flexible stem and down the separate channelwithin the hollow tube.

A further aspect is a universal connector comprising: a continuoushollow funnel shape having a larger opening at a first end and a smalleropening at a second end; an engagement apparatus adjacent to the secondend; and protrusions operatively attached to the engagement apparatus sothat when the second end of the universal connector is placed into aproximal end of a medical device the protrusions on the engagementapparatus can operatively engage with a locking mechanism on theproximal end of the medical device to permit fluid communication betweenthe universal connector and the medical device.

Additional aspects are illustrated and described herein.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 illustrates a side profile of an embodiment of the medical deviceimplanted in a patient with the first cap unsecured to the hollow tube.

FIG. 2 illustrates a side profile of an embodiment of the medical deviceimplanted in a patient with the first cap secured to the hollow tube.

FIG. 3 illustrates a side profile of an embodiment of the medical deviceimplanted in a patient with the first cap unsecured to the hollow tubeand a syringe.

FIG. 4 illustrates an alternative side profile, rotated 90 degrees fromFIG. 1-3, of an embodiment of the medical device with an emphasis on theproximal end of the medical device.

FIG. 5 illustrates a top view of an embodiment of the medical device.

FIG. 6 illustrates a top view of an embodiment of the medical devicewith an emphasis on one embodiment of the valve and locking mechanismlocated at the proximal end of the medical device.

FIG. 7 illustrates a top view of an embodiment of the medical devicewith an emphasis on an alternative embodiment of the valve and lockingmechanism located at the proximal end of the medical device.

FIG. 8 illustrates a side profile, 90 degrees from FIG. 1-3, of anembodiment of the medical device with an emphasis on the flexibility ofthe wings at the proximal end of the medical device.

FIG. 9a illustrates a side profile, 90 degrees from FIG. 1-3, of anembodiment of the medical device with an emphasis on the configurationfor receiving a second cap.

FIG. 9b illustrates a side profile, 90 degrees from FIG. 1-3, of anembodiment of the medical device with an emphasis on the configurationfor receiving a second cap.

FIG. 10a illustrates an embodiment of a second cap of the presentdisclosure having a single port within the cap.

FIG. 10b illustrates an embodiment of a second cap of the presentdisclosure having a larger single port within the cap than theembodiment in FIG. 10 a.

FIG. 10c illustrates an embodiment of a second cap of the presentdisclosure having a larger single port within the cap than theembodiment in FIG. 10a or FIG. 10 b.

FIG. 10d illustrates an embodiment of a second cap of the presentdisclosure having two ports within the cap, one larger and one smaller.

FIG. 10e illustrates an embodiment of a second cap of the presentdisclosure having four ports within the cap.

FIG. 10f illustrates an embodiment of a second cap of the presentdisclosure having two ports within the cap.

FIG. 11 illustrates steps medical personnel may take for replacing anold medical device with a new medical device of the present disclosure.

FIG. 12 illustrates steps medical personnel may take for replacing anold medical device with a new medical device of the present disclosure.

FIG. 13 illustrates steps medical personnel may take for replacing anold medical device with a new medical device of the present disclosure.

FIG. 14 illustrates steps medical personnel may take for inserting a newmedical device of the present disclosure where a tract did notpreviously exist.

FIG. 15 illustrates steps medical personnel may take for inserting a newmedical device of the present disclosure where a tract did notpreviously exist.

FIG. 16 illustrates an embodiment where the hollow tube of the medicaldevice has three different regions of longitudinal rigidity.

FIG. 17 illustrates the general anatomy of a male penis and bladder.

FIG. 18 illustrates the general anatomy of a male penis and bladder(side view) with a medical device inserted up the urethra of the malepenis and terminating in the bladder. The first cap is unsecured to thehollow tube and the balloon is deflated.

FIG. 19 illustrates the general anatomy of a male penis and bladder(side view) with a medical device up the urethra of the male penis andterminating in the bladder. The first cap is secured to the hollow tubeand the balloon is inflated.

FIG. 20 illustrates a close up view of FIG. 18 with the addition of anembodiment of the locking mechanism located at the proximal end of themedical device.

FIG. 21 illustrates a close up view of FIG. 18 with the addition of anembodiment of the locking mechanism located at the proximal end of themedical device and a universal adapter connected to the proximal end ofthe medical device via the locking mechanism.

FIG. 22 illustrates an alternative embodiment of a universal adapter.

FIG. 23 illustrates an embodiment of a universal adapter with anadditional tube, e.g., drainage tube, inserted into the end of theuniversal adapter that does not connect to a medical device via alocking mechanism.

FIG. 24 illustrates the general anatomy of the female genitalia (sideview) and bladder with a medical device inserted up the urethra andterminating in the bladder. The first cap is unsecured to the hollowtube and the balloon is deflated.

FIG. 25 illustrates the general anatomy of the female genitalia (sideview) and bladder with a medical device inserted up the urethra andterminating in the bladder. The first cap is secured to the hollow tubeand the balloon is inflated.

FIG. 26 illustrates the general anatomy of a patient's kidney and back(side view) with a medical device inserted through the back of thepatient and terminating in the kidney. The first cap is unsecured to thehollow tube and the balloon is deflated.

FIG. 27 illustrates the general anatomy of a patient's kidney and back(side view) with a medical device inserted through the back of thepatient and terminating in the kidney. The first cap is secured to thehollow tube and the balloon is inflated.

FIG. 28 illustrates a graduated measuring device of the presentdisclosure with graduated markings for accurately determining thedistance between the patients skin and the termination point for amedical device.

FIG. 29 illustrates steps medical personnel may take for inserting amedical device of the present disclosure through the back and into thekidney of a patient.

FIG. 30 illustrates steps medical personnel may take for inserting amedical device of the present disclosure up the urethra and into thebladder of a patient.

FIG. 31 illustrates a side profile of an embodiment of the medicaldevice like FIG. 3 with the first cap unsecured to the hollow tube and asyringe operatively connected to the first cap. The balloon-likecomponent is inflated.

FIG. 32 illustrates a view of a graduated measuring device of thepresent disclosure like FIG. 28 with graduated markings for accuratelydetermining the distance between the patients skin and the terminationpoint for a medical device. The balloon-like component is inflated.

FIG. 33 illustrates a side profile of an embodiment of the medicaldevice like FIG. 3 with the first cap unsecured to the hollow tube and asyringe operatively connected to the first cap. The balloon-likecomponent is inflated.

FIG. 34 illustrates an embodiment of the medical device with the firstcap unsecured to the hollow tube, a syringe, and a universal connector.

FIG. 35 illustrates an embodiment of the medical device with the firstcap unsecured to the hollow tube and a universal connector operativelyconnected to the medical device through an embodiment of the lockingmechanism.

FIG. 36 illustrates an embodiment of the medical device in two differentsizes with the first caps unsecured to the hollow tubes, a syringe, anda universal connector.

FIG. 37 illustrates an embodiment of the medical device with the firstcap unsecured to the hollow tube, a syringe, and a universal connector

FIG. 38 illustrates an embodiment of the medical device with the firstcap unsecured to the hollow tube and a universal connector operativelyconnected to the medical device through an embodiment of the lockingmechanism.

DETAILED DESCRIPTION

There is a need in the art for low-profile long-term device that allowsport-like access to the urinary bladder or kidney of a patient withoututilizing a patient's urethra. The device should allow a patient'sbladder or kidney to drain as well as permit medical personnel access tothe urinary bladder or kidney to diagnose and treat bladder or kidneyproblems. In addition, the low profile of the device should limit ordecrease inadvertent removal of the device by confused patients, i.e.,patients suffering from dementia, neural injury, trauma, medication orin the internal care unit. The present disclosure overcomes theshortcomings of the prior art and addresses these needs in the art.

There is also an additional need in the art for a low-profile long-termdevice that allows port-like access to the urinary bladder of a patientby utilizing a patient's urethra. The device should allow a patient'sbladder to drain as well as permit medical personnel access to theurinary bladder to diagnose and treat bladder problems.

In addition, there is an additional need in the art for graduatedmeasuring device to allow a physician to determine the distance betweenthe patient's skin and kidney or urinary bladder thereby allowing thephysician the ability to accurately select a device for insertion thatwill snugly fit the patient. Finally, there is a need in the art foruniversal connector that allows a large variety of medical tubing tofluidly and/or operatively connect to a medical device of the presentdisclosure.

Referring now to the drawings wherein like reference numerals designateidentical or corresponding parts throughout the several views, anembodiment of medical device implanted in a patient with the first capunsecured to the hollow tube is shown in FIG. 1. In an embodiment, amedical device has a continuous hollow tube 16 for spanning the distancebetween an exterior surface of a patient's suprapubic region 8 and thepatient's urinary bladder 10 having a diameter between 10 french and 40french and a length between 0.8 cm and 15 cm, the hollow tube having anopen proximal end 3 and an open distal end 14, the proximal end 3 of thehollow tube 16 being longitudinally more rigid than the distal end 14.The first cap 2 having a top surface and bottom surface that isoperatively configured for securely attaching to the proximal end 3 ofthe tube 16, the cap covering the open proximal end 3 of the tube 16when securely attached to the proximal end 3 of the tube 16, the bottomsurface of the cap 1 being recessed within the proximal end 3 of thetube 16 upon secure attachment.

A hollow flexible stem 26 fluidly connects the cap 2 and the proximalend 3 of the hollow tube 16 so that liquid may pass into the bottomsurface of the cap 1, through the hollow flexible stem 26 and into aseparate channel 25 within the hollow tube 16. The fluidly separatechannel 25 runs from the proximal end 3 of the hollow tube 16 toward thedistal end 14 of the hollow tube 16, and the hollow flexible stem 26 ispermanently attached to the hollow tube 16 below the open proximal end 3of the hollow tube 16.

The medical device may further comprise an inflation port 6 on thebottom surface of the cap 2. The inflation port 6 is operativelyconfigured to receive liquid via a syringe 29 so when the cap 2 is notsecurely attached to the proximal end 3 of the tube 16 liquid may beinjected via the inflation port 6 and travel from the cap 2, through thehollow flexible stem 26 and down the separate channel 25 within thehollow tube 16.

In some embodiments, the diameter of the hollow tube 16 is between 10french and 50 french (6 Fr-50 Fr). However, in additional embodimentsthe diameter of the hollow tube may change depending on the patient'sneeds and the medical personnel's preferences. For example, the medicalpersonnel may require a larger diameter to permit the use of multiple ordifferent instruments depending on the anticipated medical procedure. Inanother example the size of the patient may dictate the diameter of thehollow tube, i.e., a patient with a larger suprapubic region 8 mass ordistance between the suprapubic region 8 and bladder 10 may require alarger diameter tube 16.

In certain embodiments the diameter of the tube 16 will be between 15french and 35 french, between 20 french and 30 french, between 10 frenchand 30 french, between 10 french and 20 french, between 20 french and 40french or between 30 french and 40 french.

In some embodiments the diameter of the tube will be greater than 10french, greater than 20 french, greater than 30 french or greater than40 french. In other embodiments the diameter of the tube will be lessthan 50 french, less than 40 french, less than 30 french or less than 20french.

It will be appreciated that in some embodiments the tube 16 has asubstantially continuous diameter from the proximal end 3 to the distalend 14. However, in some embodiments the diameter of the tube 16 maychange. For example, the proximal region 22 of the tube may be onediameter, while the distal region 18 of the tube 16 is a similar ordifferent diameter and the medial region 20 of the tube is a similar ordifferent diameter. The difference in diameters may be important tohelping control how rigid the tube 16 is or helping to prevent themedical device from accidently coming out. In some embodiments thediameter of the tube 16 will gradually increase or decrease from theproximal end 3 to the distal end 14.

In some embodiments, the length of the hollow tube 16 is between 0.8 cmand 40 cm. However, in additional embodiments the length of the hollowtube may change depending on the patient's needs and the medicalpersonnel's preferences. For example the size of the patient may thelength of the hollow tube, i.e., a patient with a larger suprapubicregion 8 mass or distance between the suprapubic region 8 and bladder 10may require a longer tube 16.

In certain embodiments the length of the tube 16 will be between 5 cmand 25 cm, between 10 cm and 20 cm, between 0.8 cm and 20 cm, between0.8 cm and 10 cm, between 5 cm and 30 cm, between 10 cm and 30 cm,between 15 cm and 30 cm or between 20 cm and 30 cm.

In some embodiments the length of the tube 16 will be greater than 3 cm,greater than 8 cm, greater than 12 cm, greater than 18 cm, greater than22 cm or greater than 26 cm. In other embodiments the length of the tube16 will be less than 30 cm, less than 25 cm, less than 20 cm, less than15 cm, less than 10 cm or less than 5 cm.

Still referring to FIG. 1 (see also FIG. 16), in some embodiments theproximal end 3 of the hollow tube 16 is longitudinally more rigid thanthe distal end 14. In other embodiments, proximal end 3 of the hollowtube 16 is longitudinally less rigid than the distal end 14. Thedifference in rigidity may be important to improving comfort to apatient, e.g., less rigid within the proximal region 22, or providingattributes to enhance a medical personnel's ability to manipulateinstruments through the tube, e.g., more rigid in the distal region 18.In certain embodiments the entire tube 16 will have the same rigidity orflexibility. However, in other embodiments the rigidity may differbetween the distal 14 and proximal 3 ends or the distal 18 and proximalregions 22 of the tube 16. In some embodiments the tube may comprisethree regions, a proximal region 22, a medial region 20 and a distalregion 18. Each region may have a different rigidity or similarrigidity.

In certain embodiments the rigidity of the one region to another region,or proximal end 3 to distal end 14 (and vice versa), may be at least 1.0time more rigid, at least 1.5 times more rigid, at least 2.0 times morerigid, at least 2.5 times more rigid, or at least 3.0 times for rigid.In additional embodiments the difference in rigidity between regions onthe hollow tube may be between 1.0 and 10 times, between 2.0 and 8.0times, or between 3.0 and 6.0 times.

Still referring to FIG. 1, the tube 16, and sometimes the entire deviceis made from silicone or latex, although any biocompatible material issuitable. In a preferred embodiment the tube or the device issubstantially clear.

Still referring to FIG. 1, the first cap 2 is operatively configured forsecurely attaching to the proximal end 3 of the tube 16. The secureattachment may occur through a variety of suitable arrangements,including typical male-female connections. In an embodiment the firstcap 2 snaps into the opening in the proximal end 3 of the tube 16 (e.g.,FIG. 2). In all methods of secure attachment once the first cap issecurely attached to the proximal end, the proximal end is no longeropen and a force is required to disengage the first cap 2 from theproximal end 3.

When the first cap 2 is securely attached to the proximal end 3 of thetube 16, the inflation port 6 and inflation port valve 4 are recessedwithin the proximal end 3 of the hollow tube 16, e.g., FIGS. 2 and 4.This configuration allows the medical device to have a lower and smallerprofile upon insertion to the patient, e.g., the amount of the devicethat protrudes above the patient's suprapubic skin 8 is reduced byallowing the inflation port 6 and inflation port valve 4 to recesswithin the hollow tube 16.

In an embodiment the inflation port 6, the inflation port valve 4, thehollow flexible stem 26 and the separate channel 25 are in fluidcommunication and isolated from any fluid that may flow between thepatient's skin surface at the suprapubic region 8 and the patient'sbladder 10 via the tube 16.

The inflation port 6 on the bottom surface of the cap 2 is capable ofreceiving liquid via a syringe 29 or equivalent device. In someembodiments, the inflation port 6 has a built in one way valve toprevent liquid from accidently or inadvertently flowing out theinflation port 6 without operator manipulation. In other embodiments, aninflation port valve 4 is also present and performs substantially thesame function, i.e., prevent liquid from accidently or inadvertentlyflowing out the inflation port 6 without operator manipulation.

In some embodiments, the medical device further comprises an inflatableballoon-like component 12 that is fluidly connected to the separatechannel 25 and capable of receiving air or liquid via the inflation port6. The balloon like component 12 is affixed to the tube 16 prior toinsertion of the medical device into a patient. The balloon-likecomponent 12 may be affixed to the tube 16 in a variety of fashionsincluding affixation to the exterior surface of the tube 16, theinterior surface of the tube 16, directly to the separate channel 25, orsome combination thereof In all embodiments the balloon-like componentis in fluid communication with the separate channel 25 and fluidlyisolated from the tube 16 or patient's bladder 10.

When the medical device is inserted into a patient the balloon-likecomponent 12 is substantially empty of water or air, i.e., deflated asshown in FIG. 1. Following insertion of the medical device, theballoon-like component 12 is inflated using liquid or air via theinflation port 6 as shown in FIG. 3. Upon inflation, the balloon-likecomponent rests against the bladder wall to help hold the medical devicein place and prevent the medical device from backing out of the patient.In some instances, the inflated balloon-like component will act as aplug to help prevent liquid from inadvertently leaking from the bladdervia the channel in the patient's suprapubic region, i.e., not via themedical device. In a preferred embodiment, the balloon-like componenthas a donut-like shape when inflated as opposed to a morebasketball-like shape. When it is necessary to remove the medicaldevice, liquid or air is removed from the balloon-like component via theinflation port 6. Removal of the liquid or air deflates the balloon-likecomponent 12, allowing removal of the medical device.

In some embodiments, the balloon-like component 12 is substantiallyflush with the distal end 14 of the tube 16 after inflation. In otherembodiments the balloon-like component 12 is recessed from the distalend 14 of the tube 16 after inflation, i.e., the balloon-like componentis a small distance toward the proximal end 3 of the tube therebyleaving a gap between the distal end 14 of the tube and the inflatedballoon-like component 12. The placement of the balloon-like component12 at a flush or recessed position with the distal end 14 preventsmedical instruments from contacting and possibly puncturing theballoon-like component during procedures. In addition, the location ofthe balloon-like component prevents it from interfering with the flow offluids, i.e., urine, between the surface of the patient's skin and thepatient's bladder via the tube 16.

Referring to FIG. 1, in some embodiments the proximal end 3 of the tube16 may further comprise a one way valve 24 located within the tube 16 ofthe medical device to prevent liquid from traveling from the patient'surinary bladder to the proximal surface of the patient's suprapubicregion without additional manipulation. In an embodiment the one wayvalve 24 prevents the flow of liquid irrespective of whether the firstcap 2 is securely configured to the proximal end 3 of the tube 16.Therefore, in an embodiment the one way valve 24 prevents liquid fromescaping the bladder when the first cap is not securely attached to theproximal end of the tube. In some embodiments the one way valve 24allows liquid, e.g., urine, to travel from the bladder upon manipulationby medical personnel or patient, for example, following the attachmentof a catheter drainage tube to the proximal end of the medical device.

In some embodiments the one way valve is flexible, e.g., rubber orlatex, and allows the insertion of medical instruments through the tubeinto a patient's bladder without breaking or substantially altering thepurpose of the one way valve 24.

Referring now to FIG. 4 and FIG. 5 which disclose an alternative sideprofile (FIG. 4) or top profile (FIG. 5), rotated 90 degrees from FIG.1-3, of embodiments of the medical device with an emphasis on theproximal end of the medical device. In FIG. 4, the first cap 2 alongwith an inflation port 6 and inflation port valve 4 are securelyattached to the proximal end of the tube 16. The flexible stem is notshown in FIG. 4 as it is hidden behind the first cap 2. Shown in FIG. 4is an embodiment of the medical device that includes suture anchors 30for suturing the medical device to the patient's skin after insertion ofthe device. The suture anchors 30 are located within the retention wings34 that span out from the proximal end 3 of the tube 16. As shown inFIG. 4, the suture anchors are hollow holes within a raised portion ofthe retention wings 34 that allow a medical operator to thread a suturethrough the holes and into a patient's skin. While hollow holes areshown in FIG. 4, the suture anchors 30 may take on any number ofconfigurations suitable for helping maintain the placement of thesuture, e.g., indentations in the surface of the retention wings 34 orraised bevels on the surface of the retention wings 34. There may be asingle suture anchor 30 or a plurality of suture anchors 30.

The retention wings 34 protrude outward from the first cap 2 as shown intop view of the medical device with a first cap 2 securely attached tothe proximal end of the tube 16 in FIG. 5. As shown in FIG. 4 theretention wings 34 have a low profile and sit adjacent to a patient'sskin following insertion of the medical device. As shown in FIG. 5 theretention wing ends 28 are a circular shape; however, the retention wingends 28 may take on any shape. In one embodiment, the retention wingends 28 are wider than the suture anchors 30 to help stabilize thesutures. The retention wings 34 not only provide a platform for thesuture anchors 30 but also provide a surface area to oppose theballoon-like component 12 following inflation. This oppositionstabilizes the placement of the medical device and prevents the medicaldevice from inadvertently being pushed farther into the patient orpulled out of the patient.

Referring now to FIG. 8, the retention wings 34 are elastic and flexiblein some embodiments. In these embodiments medical personnel or a patientmay use the retention wings 34 to grip the medical device duringinsertion or removal by using an opposing finger and thumb to pushinward and upward (as indicated by the arrows). The flexibility of theretention wings 34 provides better grip and control over the deviceduring placement and removal.

Some embodiments of the medical device will comprise a locking mechanismat the proximal end 3 of the tube 16, e.g., as shown in FIG. 6 and FIG.7. FIG. 6 and FIG. 7 are both a top view of an embodiment of the medicaldevice when the first cap 2 with inflation port 6 are not securelyattached to the proximal end 3 of the tube 16, e.g., the first cap 2 isin an open configuration and the viewer is looking directly down thetube 16. The locking mechanism is used to attach external devices, e.g.,drainage tubing, to the proximal end of the medical device. For example,when a patient or medical personnel desires to drain the bladder of thepatient, they may open the cap 2, and attached a drainage tube to theproximal end 3 of the tube 16 so that the drainage tube and tube are influid communication via the locking mechanism. The locking mechanismholds the drainage tube in place and allows liquid to flow freely fromthe patient's bladder to a source outside the patient's body. It isimportant to note that the presence of the locking mechanism does notprevent instrument access to a patient's bladder via the tube 16 when adrainage tube is not attached to the tube 16.

In some embodiments, the medical device further includes cathetertubing, e.g., drainage tube, that is manufactured and sold with at leastone end of the tubing configured to operatively connect to a specificlocking mechanism on the proximal end 3 of the tube 16. In someembodiments, when the medical device has a locking mechanism, themedical device also comes with a separate corresponding mate to thelocking mechanism that can connect (plug into an open end of the tubingor clamp around an open end of the tubing) to standard catheter tubingthereby allowing the standard catheter tubing to operatively connect tothe locking mechanism of the medical device.

FIG. 6 shows an embodiment of the present disclosure with a twistlocking mechanism 38 that allows the connection of external devices viathe twist lock 38. This locking mechanism, usually made of plastic, haskey holes that match the external drainage tubing teeth. Once theexternal drainage tubing with teeth are placed into position, thepatient or medical personnel placing the tubing just twists the drainagetubing teeth to the right and the drainage tubing teeth lock into place.Once drainage is finished, a simple twist in the opposite directionmoves the teeth back into the keyhole tracts and one lifts the tubingout.

FIG. 7 shows an embodiment of the present disclosure with a push-buttonlocking mechanism. This locking mechanism (usually made of plastic) hastwo sets of teeth or pins 40 and 42 that when in an untouched or naturalstate are plunged toward the center of the tube. When medical personnelor patient wants to insert a drainage tube, the teeth or pins 40 and 42are pinched open by applying pressure to the opposite ends of the tube16 to allow placement of the drainage tubing. Once the tubing is inplace, the pressure is released and the teeth or pins 40 and 42 settlein and lock over a ridge on the drainage tubing. In some embodiments, nolocking mechanism is necessary or alternative mechanisms for connectingexternal tubing or instruments are employed.

Referring now to FIGS. 9a and 9b , some embodiments of the presentdisclosure comprise a ridge 44 at the proximal end of the tube 16. Theridge sits above the surface of the retention wings 34 and does notinterfere with the ability of the first cap 2 to securely attach to theproximal end of the tube 16. In some embodiments the attachment of thefirst cap 2 to the proximal end of the tube is via the ridge 44. Theridge 44 is operatively configured to accept a second cap 46 via athread mechanism, a snap mechanism or similar removable but secureattachment. A second cap 46 is independent of the medical device and isnot permanently attached to the medical device. Medical personnel mayscrew or snap a second cap 46 into place via the ridge 44 when the firstcap 2 is in the open position, e.g., FIG. 3.

A second cap 46 may be solid, i.e., have not holes or may include avariety of ports 48-66 as shown in FIG. 10a-10f . The ports may take ona circular shape or any other shape and size, and may be placed atdistinct positions within a second cap. In an embodiment a second caphas two circular ports (FIG. 10f ) and is placed over the open proximalend of a tube via the ridge 44. In an embodiment each port has a rubbercover that may be penetrated by an instrument medical personnel mayplace into the patient's bladder via the medical device. In someembodiments the rubber covers have flexible slits 69 that enhancepenetration by a medical instrument.

In an embodiment medical personnel may remove the first cap 2 and placea second cap 46 with two ports 66 and 68 onto the medical device via theridge 44. The medical personnel will then access the patient's bladderfor purposes of treatment or diagnosis with instruments via the twoports 66 and 68. One advantage of using a second cap 46 with ports is todecrease the size of the opening directly into the patient's bladder viathe medical device and minimize the chance of infection.

A major advantage to the medical device of the present disclosure isthat is minimizes the amount of the device protruding from a patient'ssuprapubic region by putting the inflation port 6 into the first cap 2of the device. This is a huge advantage over current devices because itless likely to become inadvertently removed, decreases the chances forinfection and increases patient comfort. This leads to increased patientconfidence and the likelihood a patient will comply with treatment. Insome embodiments, the proximal end 3 of the device with first cap 2 andretention wings 34 sits substantially flush with the skin of the patientafter insertion of the device. In an embodiment the top of the medicaldevice after insertion into a patient is less than 1 inch from thepatient's skin, less than 0.75 inches from the patient's skin, less than0.5 inches from the patient's skin, less than 0.4 inches from thepatient's skin, is less than 0.3 inches from the patient's skin, is lessthan 0.2 inches from the patient's skin, is less than 0.1 inches fromthe patient's skin.

In an embodiment, the inflation port of the medical device is at leastpartially beneath the skin of the suprapubic region of the patient afterinsertion of the device and when the cap is securely attached to theproximal end of the tube.

Referring now to FIG. 11 where an example method 70 for replacing an oldmedical device spanning the suprapubic region and urinary bladder of apatient with a device of the present disclosure is described. First,medical personnel insert a guide wire into the hollow channel of the olddevice 72. The old device is then removed by slipping it over the guidewire and leaving the guide wire in place, i.e., spanning the distancebetween the patient's suprapubic region and urinary bladder 74. A deviceof the present disclosure is then inserted over the guide wire and intoposition 76.

FIG. 12 discloses an additional method 80 of the present disclosure.First medical personnel insert a guide wire into the hollow channel ofthe old device 82. The old device is then removed by slipping it overthe guide wire and leaving the guide wire in place, i.e., spanning thedistance between the patient's suprapubic region and urinary bladder 84.The bladder of the patient if then filled with liquid to expand thepatient's bladder 86. The distance between wall of the patient's bladderand the surface of the patient's suprapubic region is measured, e.g.,using a depth gauge, i.e., graduate measuring device 88. Measuring thedistance allows the medical personnel to choose a medical device of thepresent disclosure with the best length for fitting the patient. In anembodiment the depth gauge is designed much like a council tip catheterwith a drainage attachment area and balloon inflation port at one end,which allow for access of a guide wire during placement and ballooninflation and deflation while determining the depth of device necessaryfor patient body size. The depth gauge can be clear and have black hashmarks on the side measuring the distances from just above the balloon toalmost the drainage tip. There is a moveable surface lock that rests onthe skin edge, where the depth gauge disc will rest, and will define thedepth of the device needed, by looking at the hash mark that it relatesto. The internal end of the depth gauge has a balloon for inflation andto hold depth gauge in place while measuring, and has a council tip thatallows for the guide wire to pass through centrally.

Still referring to FIG. 12, after determining to the depth of thepreviously established tract, a properly sized medical device of thepresent disclosure is inserted into the patient over the guide wire 90.The patient's bladder is then drained 92. In some embodiments, e.g.,FIG. 13, a larger tract may be necessary then the tract previouslyestablished by the old medical device. In this situation, medicalpersonnel may dilate the existing tract to a desire french size 106 inbetween removing the old device 104 and inserting the new device 112.

Referring now to FIG. 14 where a method 120 for inserting device bycreating a new tract between a patient's suprapubic region and urinarybladder is disclosed 120. First medical personnel will insert a needleabove the patient's pubic symphisis into the patient's urinary bladder122. A guide wire is then threaded through the needle 124. The needle isremoved and a medical device is inserted into the tract created by theneedle and over the guide wire 126.

FIG. 15 discloses an additional method 130 for inserting a device bycreating a new tract between a patient's suprapubic region and urinarybladder. To aid the medical personnel in creating new tract a cystoscopeis placed into the patient's bladder via the patient's urethra 132.Medical personnel will insert a needle above the patient's pubicsymphisis into the patient's urinary bladder 134 under observation ofthe cystoscope. A guide wire is threaded through the needle 136 and theneedle is removed. The tract created by the needle and occupied by theguide wire is dilated to a desired french size 138. The depth of thetract is measured 140 using a depth gauge as previously described 88 andin some embodiments the bladder may be filled with liquid prior tomeasuring the depth. The device is selected based on the measured depthand inserted into the patient over the guide wire through the newlyformed tract 142. In some embodiments the patient's bladder is thendrained if it was full or had been filled earlier in the procedure 144.

A method for inserting a medical device is disclosed comprisinginserting a needle from a patient's exterior surface of a suprapubicskin through the patient's abdominal region and into the patient'surinary bladder to create a tract. Threading a guide wire through theneedle so the guide wire travels from the suprapubic skin into theurinary bladder and removing needle while leaving the guide wire in thetract. Dilating the tract to a desired width and measuring a distancebetween the patient's suprapubic skin and the patient's urinary bladdervia the tract. And inserting a medical device suitable for use based onthe previously measure distance.

In another embodiment a method for replacing a medical device comprisesplacing a guide wire from a patient's suprapubic skin through thepatient's abdominal region and into the patient's urinary bladder, theguide wire traveling from the suprapubic skin into the urinary bladderwithin a previously placed medical device. And removing the previouslyplaced medical device by sliding the device along the guide wire andaway from the patient; filling the bladder of the patient and measuringa distance between the patient's suprapubic skin and the patient'surinary bladder; selecting a second medical device suitable for usebased on the previously measured distance and inserting the selectedmedical device; and draining the urinary bladder of the patient.

It should be noted that the suprapubic location of the medical devicedecreases infection rates in comparison to intraurethralcatheterization. In addition, the low profile design of the medicaldevice has less material for contact and infection. In addition, anantimicrobial may be applied to the entire device or the tube to reducethe possibility of infection and increase the length of use overtraditional suprapubic tubes.

Referring now to FIG. 17 which generally shows a side view of the malepenis and surrounding anatomy. The surface of the patient's pelvic skin202 overlays the male pubic bone 206 and connects to the penis 208. Themale urethra 212 extends from the tip of the penis 208 into the malebody, past the prostate gland 204 and into the male bladder 200.

Referring to FIG. 18, in an embodiment of the present disclosure, amedical device is designed for insertion into the urethra 212 of themale penis 208 and terminates in the bladder 200 of the patient. Anembodiment of a medical device for insertion into the male urethra islike the previously discussed embodiments for insertion between anexterior surface of a patient's suprapubic region 8 and the patient'surinary bladder 10.

In an embodiment designed for insertion into a male's urethra, acontinuous hollow tube 16, spanning the distance between an exteriorsurface of a patient's penis 208 and the patient's urinary bladder 200may have a diameter between 1 french and 70 french and a length between0.5 cm and 50 cm. Embodiments contemplated by this disclosure are notlimited to the disclosed diameters and lengths. The appropriate diameterand length will be dependent on the application and patient's anatomyand/or physique. The diameter of the hollow tube 16 and the length ofthe hollow tube 16 will vary depending on the patient's anatomy andphysical condition. For example, a physician may determine theappropriate length of the hollow tube 16, and therefore thecorresponding size of the medical device, by measuring the distance fromthe tip of the male patient's penis to the bladder using a depth gaugeor graduated measuring device (e.g., FIG. 28).

In an embodiment, a medical device of the present disclosure designedfor insertion into a male's urethra will not have a one way valve 24(not pictured) while in other embodiments it may. Still referring toFIG. 18, following insertion of the medical device into the malepatient's urethra, the first cap 2 is not secured to the proximal end 3of the tube 16. The distal end 14 terminates within the male patient'surethra so that the inflated balloon-like component 12 is within thepatient's urethra (deflated in FIG. 18.)

Referring now to FIG. 19, following insertion of the medical device, theballoon-like component 12 is inflated via the inflation port 6 so thatthe balloon-like component 12 keeps the medical device in place andprevents accidental removal. In a preferred embodiment, the medicaldevice is sized to the patient's anatomy so that following inflation ofthe balloon-like component the proximal end 3 of the medical device(including the first cap 2, the inflation port valve 4, the inflationport 6) fit snugly against the tip of the male patient's penis 208. Asnug fit is preferred so that the medical device is low-profile and doesnot unnecessarily snag on clothing or external objects. In someembodiments, retention wings 34 (not shown) help keep the medical devicesnugly placed.

Referring now to FIG. 20, in an embodiment the proximal end of thehollow tube 16 will have a locking mechanism (e.g., FIG. 6 and FIG. 7)which in some embodiments is recessed slots 41. As previously describedthe locking mechanism allows external devices, e.g., drainage tubing, tooperatively attach to the medical device.

Referring now to FIG. 21, one aspect of the present disclosure is auniversal connector 210. While the universal connector shown in FIG. 21has a conical shape, it may have a variety of different shapes. Theuniversal connector 210 has a proximal end 216 and a distal end 218.Adjacent to the distal end 218 the universal connector has an engagementapparatus 212 that includes protrusions 214 designed to operativelyinteract with the recessed slots 41 in the medical device. Uponinsertion the distal end 218 of the universal connector 210 a medicaldevice of the present disclosure, the engagement apparatus 212 and itsprotrusions 214 will securely affix the universal connector to themedical device so that fluid may flow from a patient's body, through themedical device and out of the proximal end 216 of the universalconnector 210. The embodiment of the engagement apparatus 212 andlocking mechanism (recessed slots 41) shown in FIG. 21 is merelyrepresentative of the type of engagement male/female engagementcontemplated by this disclosure. The important aspect of this disclosureis that the engagement apparatus of the universal connector 210 iscapable of operatively interacting with the locking mechanism of themedical device. For example, the locking mechanism may be similar torecessed slots 41 or similar to the twist locking mechanism 38 (e.g.,FIG. 6) or push-button locking mechanism (e.g., FIG. 7). The engagementapparatus 212 will vary depending on the locking mechanism used by themedical device.

In some instances, the universal connector 210 is made of a resilientand pliable material, like silicone or rubber, that allows a user topinch the sides of the distal end of the universal connector together tofacilitate insertion of the distal end 218 of the universal connector210 into the proximal end 3 of the medical device, thereby allowing theengagement apparatus 212 to operatively interact with the lockingmechanism.

Referring now to FIG. 22, in some embodiments the engagement apparatus212 will be capable of moving (e.g., because the engagement apparatushas elastic properties like a rubber band) along a distance D1 from thedistal end 218 of the universal connector 210. In some embodiments, thiswill allow a user to push the distal end 218 of the universal connector210 farther into the proximal end 3 of the medical device before theengagement apparatus 212 engages the locking mechanism (e.g., 41.)

Referring now to FIG. 23, the proximal end 216 of the universalconnector 210 is designed to accept a variety of different size andshaped medical tubing 220 so that a universal connector 210 may be usedto operatively and/or fluidly connect a variety of medical tubing to amedical device of the present disclosure. For example, a user mayunsecure the first cap 2 of a medical device placed in the urethra (orother place as descried in this disclosure) of a patient. The user maythen operatively affix a universal connector 210 to the proximal end ofthe medical device using an engagement apparatus 212 compatible with thelocking mechanism of the medical device within the patient (e.g., FIG.6, FIG. 7 and FIG. 20). Once the universal connector is affixed to themedical device, a user may then place the distal end 222 of any varietyof different diameter medical tubing 220 into the proximal end 216 ofthe universal connector 210. The user may then drain fluid from apatient's body whereby the fluid leaves the bladder 200 of the patient,traveling from the distal end 14 to the proximal end 3 of the medicaldevice, through the universal connector 210 and into the medical tubing220.

Referring now to FIG. 24, in an embodiment of the present disclosure, amedical device is designed for insertion into the urethra 234 of afemale and terminates in the bladder of the patient 228. An embodimentof a medical device for insertion into the female urethra is like thepreviously discussed embodiments for insertion between an exteriorsurface of a patient's suprapubic region 8 and the patient's urinarybladder 10.

In an embodiment designed for insertion into a female's urethra, acontinuous hollow tube 16, spanning the distance between an exteriorsurface of a patient's labia 232, just above the patient's vagina 230 tothe patient's urinary bladder 228 may have a diameter between 1 frenchand 70 french and a length between 0.5 cm and 50 cm. Embodimentscontemplated by this disclosure are not limited to the discloseddiameters and lengths. The appropriate diameter and length will bedependent on the application and patient's anatomy and/or physique. Thediameter of the hollow tube 16 and the length of the hollow tube 16 willvary depending on the patient's anatomy and physical condition. Forexample, a physician may determine the appropriate length of the hollowtube 16, and therefore the corresponding size of the medical device, bymeasuring the distance from the surface of the female patient's labia232 to the bladder 228 using a depth gauge or graduated measuring device(e.g., FIG. 28). FIG. 24 generally discloses a female patient's anatomy(pubic bone 224, skin 226, vagina 230 and labia 232) following insertionof a medical device of the present disclosure up the urethra of thepatient and terminating in the patient's bladder. This embodimentmedical device may have the same attributes and features as describedpreviously for different embodiments of the medical device.

Referring now to FIG. 25, following insertion of the medical device, theballoon-like component 12 is inflated via the inflation port 6 so thatthe balloon-like component 12 keeps the medical device in place andprevents accidental removal. In a preferred embodiment, the medicaldevice is sized to the patient's anatomy so that following inflation ofthe balloon-like component the proximal end 3 of the medical device(including the first cap 2, the inflation port valve 4, the inflationport 6) fit snugly against the skin of the female patient's anatomy 232.A snug fit is preferred so that the medical device is low-profile anddoes not unnecessarily snag on clothing or external objects. In someembodiments, retention wings 34 (not shown) help keep the medical devicesnugly placed.

Referring now to FIG. 26, in an embodiment of the present disclosure, amedical device is designed for percutaneous insertion into a patient'skidney 240 and terminates in the pelvis of the kidney 240. In thisembodiment, a medical device of the present disclosure may replace theuse of nephrostomy tubes. Generally, medical personal may use a medicaldevice of the present disclosure for percutaneous insertion into thepelvis of a patient's kidney to achieve direct access to apart of theupper urinary tract for various procedures. In addition, kidney stonesor other blockages can stop the flow of urine from the kidneys throughureters and into the bladder. This can cause pain and a condition knownas hydronephritis. By using a medical device of the present disclosureto establish fluid connection to the pelvis of the Kidney, medicalpersonal may bypass a blocked area and allow urine to leave the bodythrough the medical device. An embodiment of a medical device forpercutaneous insertion into the pelvis of a patient's kidney is like thepreviously discussed embodiments for insertion between an exteriorsurface of a patient's suprapubic region 8 and the patient's urinarybladder 10.

In an embodiment designed for percutaneous insertion into the pelvis 241of a patient's kidney 240, a continuous hollow tube 16, spanning thedistance between an exterior surface of a patient's skin 236 (patient'sback) and the pelvis 241 of the kidney 240 may have a diameter between 1french and 70 french and a length between 0.5 cm and 50 cm. Embodimentscontemplated by this disclosure are not limited to the discloseddiameters and lengths. The appropriate diameter and length will bedependent on the application and patient's anatomy and/or physique. Thediameter of the hollow tube 16 and the length of the hollow tube 16 willvary depending on the patient's anatomy and physical condition.

FIG. 26 generally discloses a side view of a patient's kidney and thesurrounding anatomy (skin of a patient's back 236, kidney 240, pelvis241 of kidney 240) following the percutaneous insertion of a medicaldevice of the present disclosure through a patient's back 236 andterminating in the pelvis 241 of a patient's kidney 240. This embodimentof the medical device may have the same attributes and features asdescribed previously for different embodiments of the medical device.

In an embodiment, a medical device of the present disclosure designedfor percutaneous insertion into the pelvis of a patient's kidney willhave a valve 24. Still referring to FIG. 26, following the percutaneousinsertion of the medical device into the pelvis 241 of the kidney 240,the first cap 2 is not secured to the proximal end 3 of the tube 16. Thedistal end 14 terminates within the pelvis of the kidney so that theinflated balloon-like component 12 is within the pelvis 241 (deflated inFIG. 26).

Referring now to FIG. 27, following insertion of the medical device, theballoon-like component 12 is inflated via the inflation port 6 so thatthe balloon-like component 12 keeps the medical device in place andprevents accidental removal. In an embodiment, the medical device issized to the patient's anatomy so that following inflation of theballoon-like component the proximal end 3 of the medical device(including the first cap 2, the inflation port valve 4, the inflationport 6) fit snugly against the patient's skin 236. A snug fit ispreferred so that the medical device is low-profile and does notunnecessarily snag on clothing or external objects. In some embodiments,retention wings 34 (not shown) help keep the medical device snuglyplaced.

In one embodiment, the medical device for percutaneous insertion intothe pelvis of a patient's kidney does not comprise a inflatableballoon-like component. In this embodiment, the device is held snugly inplace using sutures to suture the device to the patient's skin.

Referring now to FIG. 28, another component of the present disclosure isa graduated measuring device 244 or a depth gauge for determining thedistance between points in a patient's anatomy and ultimatelydetermining what size medical device will provide the best fit for thepatient, e.g., ensuring a snug fit. The measuring device of the presentdisclosure has a proximal end 246 and a distal end 254 with a firstchannel running between the proximal 246 and distal ends 254. Themeasuring device further comprises a second channel 250 that runsbetween a port 248 and a balloon-like inflatable component 252. Themeasuring device further comprises graduated marks 256 for measurement.The diameter of the measuring device may be between 1 french and 70french and a length between 0.5 cm and 50 cm. Embodiments contemplatedby this disclosure are not limited to the disclosed diameters andlengths. The appropriate diameter and length will be dependent on theapplication and patient's anatomy and/or physique.

In an embodiment, the user will place the device into a patient'surethra until the distal end 254 of the measuring device 244, includingthe balloon-like inflatable component 252 is within the patient'sbladder. The user will then inflate the balloon-like inflatablecomponent by injecting liquid or air through the port 248, down thesecond channel 250 and into the balloon-like inflatable component 252.Once the balloon-like component 252 is inflated the user can pull on thedevice 244 to snug the inflated balloon-like component (e.g., a balloon)against the inner wall of the patient's bladder. Using the graduatemarks the user may then determine the distance between the patient'sskin, e.g., tip of a patient's penis, and the patient's bladder. Thisdistance may be used to determine the appropriate sized medical deviceto insert into the patient for longer term use. In an embodiment, thepatient may leave the graduated measuring device in place while waitingfor the appropriate size medical device to arrive.

Referring now to FIG. 29, which discloses a method 260 of the presentdisclosure. In method 260 a patient inserts a needle 262, e.g., largebore needle, into the back of a patient, piercing the patient's skin andcreating a passageway from the patient's skin to the pelvis of thepatient's kidney. The user will then thread a guide wire through theneedle 264 followed by removing the needle while leaving the guide wirein place 266. The user may then insert a medical device of the presentdisclosure (e.g., FIG. 26) over the guide wire 268 and then remove theguide wire 270. In some embodiments, a user may determine the distancebetween the patient's skin and the pelvis of the kidney using a graduatemeasuring device prior to inserting the guide wire 268.

Referring now to FIG. 30, which discloses a method 280 of the presentdisclosure. In method 280, a user insert's a graduate measuring deviceinto a patient urethra, extending into a patient's bladder 282. The userinflates the balloon-like component of the graduated measuring device284 and measures the distance between the patient's bladder and tip ofthe patient's penis 286. The user then deflates the balloon-likecomponent and removes the graduate measuring device 288. The user theninsert's a medical device of the present disclosure sized according tothe distance measured using the graduated measuring device 290.

Referring now to FIG. 31, which discloses an embodiment as previouslydiscussed using like numbers and that is particularly suitable forinsertion into a patient's suprapubic region to reach the patient'sbladder. The balloon-like component 12 is shown inflated as it would beafter insertion into a patient. The second (separate) channel 25 thatruns along the length of the device to fluidly connect the balloon-likecomponent 12 and the liquid injected using a syringe 29 is not visiblebut is present. Referring now to FIG. 32, which discloses an embodimentof a graduated measuring device 244 as previously discussed in FIG. 28.

Referring now to FIG. 33 which discloses an embodiment as previouslydiscussed using like numbers and that is particularly suitable forinsertion into a patient's urethra. Notably, a twist locking mechanism38 is shown that allows the connection of external devices via the twistlock 38. This locking mechanism, usually made of plastic but can also bemade of a variety of materials, e.g., latex, rubber, silicone or thelike, has key holes that match the external drainage tubing teeth orprotrusions 214 from the engagement apparatus 212 on a universalconnector 210. Still referring to FIG. 32, the retention wings 34 thatspan out from the proximal end 3 of the tube 16 may have a concave undersurface (surface that contacts skin) to better fit a patient's skintexture and curvature. This embodiment would be particular helpful whenthe medical device is used for insertion into a male urethra.

Referring now to FIG. 34 and FIG. 35 which disclose embodiments aspreviously discussed using like numbers and that are particularlysuitable for insertion into a patient's urethra. A particular embodimentof the universal connector 210 is shown both prior to and after it hasbeen operatively attached to an embodiment of the medical device.

Referring now to FIG. 36, FIG. 37 and FIG. 38 which disclose embodimentsas previously discussed using like numbers and that are particularlysuitable for insertion into a patient's kidney. A particular embodimentof the universal connector 210 is shown both prior to and after it hasbeen operatively attached to an embodiment of the medical device. Asshown in FIG. 38, the universal connector 210 can operatively attach tothe medical device via engagement of the protrusions 214 from theengagement apparatus 212 with the twist locking mechanism 38.

While reference has been made to a patient throughout the specificationit should be appreciated that that the patient could be any mammal.

Example 1

A medical device of the present disclosure was placed into a previouslyexisting suprapubic tract. A guide wire was placed through the devicecurrently in place and the old device was removed over the wire. A depthgauge was placed over the guide wire until then end with a balloon wasin the bladder and then the balloon was inflated. The patient's bladderwas filled with water and the clamp on the surface of the depth gaugewas clamped. The moveable surface lock on the depth gauge was moved tothe skin surface while holding up on the depth gauge. The depth wasmeasured. A matching size device of the present disclosure was selected.The depth gauge was removed and the selected device was placed over thewire and threaded into the bladder. The balloon-like component on theselected device was inflated following insertion into bladder. Thebladder was drained after connecting drainage tubing via a lockingmechanism to the inserted device. The drainage tubing was removed andthe first cap was securely attached to the proximal end of the device.The patient was instructed on use of the inserted device and how oftentheir bladder should be drained via the inserted device.

Example 2

A medical device of the present disclosure was placed into a new patientby creating a new suprapubic tract. A cystoscope was placed via urethrainto the bladder and the bladder was filled with liquid. An 18 gaugespinal needle was inserted into the patient approximately twofingerbreadths above the pubic symphisis in the midline until urinereturned from the needle and needle was visualized through thecystoscope. A guide wire was threaded through the needle. The tract wasdilated using an Amplatz balloon dilating system (but any means ofdilating will work) to the desired French size. A depth gauge was placedover the wire until the balloon was in the bladder and the balloon wasinflated. The patient's bladder was refilled and the depth gauge wasclamped. The moveable surface lock on the depth gauge was moved to thepatient's skin surface while holding up on the depth gauge and the depthwas measured. A matching size device of the present disclosure wasselected. The depth gauge was removed and the selected device was placedover the wire and threaded into the bladder. The balloon-like componenton the selected device was inflated following insertion into bladder.The bladder was drained after connecting drainage tubing via a lockingmechanism to the inserted device. The drainage tubing was removed andthe first cap was securely attached to the proximal end of the device.The patient was instructed on use of the inserted device and how oftentheir bladder should be drained via the inserted device.

Some embodiments have additional uses, for example, as a feeding tubevia port-like access to a patient's stomach, i.e., a G-button. Or forport-like access to another internal cavity of a patient.

Some embodiments involve one or more parts of the urinary system. Insome embodiments, the urinary system includes the kidneys, ureters,bladder, and urethra.

Those skilled in the art will appreciate that the present invention maybe embodied by forms that are not disclosed without departing from thespirit or fundamental attributes thereof. While the present disclosuredescribes only some of the possible embodiments, a skilled artisan willappreciate that other variations are contemplated as being with thescope of the present invention. Accordingly, the present invention isnot limited in the particular embodiments which have been described indetail therein. Since many embodiments of the invention can be madewithout departing from the spirit and scope of the invention, theinvention resides in the claims hereinafter appended.

1. A medical device comprising: a continuous hollow tube, the lengthsized for spanning the distance between an exterior surface of amammal's back and the mammal's pelvis of its kidney, the hollow tubehaving an open proximal end and an open distal end; a first cap having atop surface and a bottom surface, the first cap being operativelyconfigured for securely attaching to the proximal end of the tube; ahollow flexible stem fluidly connecting the first cap and the proximalend of the hollow tube so that liquid may pass into the bottom surfaceof the first cap, through the hollow flexible stem and into a separatechannel within the hollow tube; and an inflation port on the bottomsurface of the cap.
 2. The medical device of claim 1 wherein thecontinuous hollow tube has a diameter between 10 french and 40 frenchand the proximal end of the hollow tube is longitudinally more rigidthan the distal end.
 3. The medical device of claim 1 wherein the firstcap covers the open proximal end of the tube when securely attached tothe proximal end of the tube and the bottom surface of the cap isrecessed within the proximal end of the tube upon secure attachment. 4.The medical device of claim 1 wherein the fluidly separate channel runsfrom the proximal end of the hollow tube toward the distal end of thehollow tube and the hollow flexible stem is permanently attached to thehollow tube below the open proximal end of the hollow tube.
 5. Themedical device of claim 1 wherein the inflation port is operativelyconfigured to receive liquid via a syringe so when the cap is notsecurely attached to the proximal end of the tube liquid may be injectedvia the inflation port and travel from the cap, through the hollowflexible stem and down the separate channel within the hollow tube. 6.The medical device of claim 1 further comprising a second cap having topsurface and a bottom surface that is operatively configured to securelyattach to the proximal end of the tube, the second cap having at leastone port from the top surface through to the bottom surface.
 7. Themedical device of claim 1 further comprising a one way valve locatedwithin the tube of the medical device to prevent liquid from travelingfrom the mammal's kidney to the external surface of the mammal's skinwhen the first cap is not securely attached to the proximal end of thetube.
 8. The medical device of claim 1 further comprising an inflatableballoon along the exterior surface of the hollow tube and in fluidcommunication with the inflation port via the separate channel withinthe hollow tube.
 9. The medical device of claim 2 wherein the diameterof the continuous hollow tube is between 20 and 30 french.
 10. Themedical device of claim 2 wherein the diameter of the continuous hollowtube is greater than 30 french.
 11. The medical device of claim 2wherein the diameter of the continuous hollow tube is less than 20french.
 12. The medical device of claim 1 wherein the length of thecontinuous hollow tube is between a length between 0.8 cm and 15 cm. 13.The medical device of claim 1 wherein the length of the continuoushollow tube is greater than 8 cm.
 14. The medical device of claim 1wherein the length of the continuous hollow tube is less than 10 cm. 15.The medical device of claim 1 wherein the proximal end of the devicesits substantially flush with the skin of the back of the mammal afterinsertion of the device into the mammal.
 16. The medical device of claim1 wherein the inflation port of the device sits at least partiallybeneath the skin of the skin of the mammal after insertion of the deviceand when the cap is securely attached to the proximal end of the tube.17. A medical device comprising: a continuous hollow tube, the lengthsized for spanning the distance between an exterior surface of a mammalsskin and the mammal's pelvis of the kidney having a diameter between 10french and 40 french, the hollow tube having an open proximal end and anopen distal end; a first cap having a top surface and bottom surfacethat is operatively configured for securely attaching to the proximalend of the tube, the cap covering the open proximal end of the tube whensecurely attached to the proximal end of the tube, the bottom surface ofthe cap being recessed within the proximal end of the tube upon secureattachment; a hollow flexible stem fluidly connecting the cap and theproximal end of the hollow tube so that liquid may pass into the bottomsurface of the cap, through the hollow flexible stem and into a separatechannel within the hollow tube, the fluidly separate channel runningfrom the proximal end of the hollow tube toward the distal end of thehollow tube, and the hollow flexible stem being permanently attached tothe hollow tube below the open proximal end of the hollow tube; and aninflation port on the bottom surface of the cap, the inflation portbeing operatively configured to receive liquid via a syringe so when thecap is not securely attached to the proximal end of the tube liquid maybe injected via the inflation port and travel from the cap, through thehollow flexible stem and down the separate channel within the hollowtube. 18-26. (canceled)
 27. A universal connector comprising: acontinuous hollow funnel shape having a larger opening at a first endand a smaller opening at a second end; an engagement apparatus adjacentto the second end; and protrusions operatively attached to theengagement apparatus so that when the second end of the universalconnector is placed into a proximal end of a medical device theprotrusions on the engagement apparatus can operatively engage with alocking mechanism on the proximal end of the medical device to permitfluid communication between the universal connector and the medicaldevice.